Bleeding Score Research Articles

The early and rapid response to daratumumab in children with chronic refractory immune thrombocytopenia from a referral single centre of China.

Chronic refractory primary immune thrombocytopenia (CRITP) is currently defined as refractory to multiple therapeutic of second-line agents with or without splenectomy, faced with the threat of severe bleeding and challenging to obtain effective treatment. Although stable and effective drug therapy is needed, it is tough to find one. Daratumumab (Dara), an anti-CD38 monoclonal antibody presented the target cloned plasma cells in multiple myeloma, has also been reported to be effective in refractory autoimmune cytopenia in some case or series reports and ongoing clinical trials for adult patients with CRITP. Here, we report the early and durable response of Dara combination with avatrombopag in three CRITP patients (2 male and 1 female aged 12, 5 and 7 years, respectively) in our centre, with a follow-up period of more than 25 weeks. Before Dara, the duration of immune thrombocytopenia was 9, 1.4 and 4 years, respectively, a baseline platelet count of 4, 6, 9 × 109/L, the bleeding score was all above level 2 and the number of previous drugs was >3. The time to response (R: Plt ≥30 × 109/L with at least a twofold increase in the baseline count) of Dara was on Day 45, 6 and 4 and achieved complete response (CR: Plt ≥100 × 109/L) on Day 51, 6 and 8, the sustained response (SR: Plt >30 × 109/L following Dara at ≥75% of the platelet count assessment at follow-up end-point since the patient achieved response) was 48, 175 and 204 days with the follow-up time of 39.1, 25.9 and 29.7 weeks. The bleeding score decreased from grade 3 to grade 0 during follow-up. No significant treatment-related adverse events were found during follow-up. Dara combination with avatrombopag may be a safe and efficacious therapy for children with CRITP, but it needs to be further explored.

Airflowing as an adjunctive treatment for periodontitis: A randomized controlled trial.

The aim of this randomized controlled trial was to assess clinical and patient-reported outcomes of subgingival instrumentation (SI) with adjunctive use of erythritol airflowing (EAF)compared toSI alone in the treatmentofperiodontitis. Twenty-six participants with Stage III/IV periodontitis requiring nonsurgical periodontal treatment were randomly allocated into two treatment groups: SI with EAF or SI alone. Clinical parameters of percentage of probing pocket depths (PPDs) of ≥5mm, full mouth bleeding and plaque scores (FMBS and FMPS), and PPD values were recorded at baseline, and at 3 and 6 months posttreatment.A visual analogue scale was used to evaluatepostoperative participants' perception of pain, swelling, bleeding, bruising, and root sensitivity.The impact of periodontal treatment onquality of lifewas assessed using the General Oral Health Assessment Index (GOHAI) at six months. A total of 26 participants with Stage III/IV periodontitis completed the 6-month follow-up. SI with or without EAF resulted in a statistically significant reductions in the FMBS, FMPS, PPDs, and percentage of PPDs of ≥5mm at the 3- and 6-month follow-up visits. There was no statistically significant difference between the two treatment groups for any time interval. Participants receiving SI/EAF exhibited a higher reduction in FMBS compared to those in SI alone group at 3 (SI/EAF: 19.4±11.9, SI alone:30.1±20.5; P=0.12) and 6 months (SI/EAF: 14.3±9.6, SI alone: 24.5±18.2; P=0.09). A lower percentage of sites with deep PPDs (≥5mm) was also noted amongst participants in the SI/EAF group compared to SI alone at 3 months (SI/EAF: 14.3±14.1, SI alone:19.2±20.3; P=0.48) and 6 months (SI/EAF: 8.3±10.0, SI alone: 15.4±17.4; P=0.22). Patient-reported outcomes showed no significant differences between the two treatment groups, except in the psychosocial domain of the GOHAI at 6 months favoring the SI/EAF group (P=0.03). Within the limitations of the study, the adjunctive use of EAF in addition to SI in the treatment of Stage III/IVperiodontitisdid not result in a significant improvement in clinical parameters. Limited improvement in the QoL with EAF could be achieved.

Targeted exome analysis in patients with rare bleeding disorders: data from the Rare Bleeding Disorders in the Netherlands study

BackgroundRare coagulation factor deficiencies and disorders of fibrinolysis (defined as rare bleeding disorders [RBDs]) present with a heterogeneous bleeding phenotype, and bleeding severity is difficult to predict. ObjectivesDescribe underlying rare genetic variants in the Dutch RBD population and investigate the relationship between genotype, laboratory phenotype, and clinical phenotype. MethodsThe Rare Bleeding Disorders in the Netherlands is a cross-sectional, nationwide study conducted between October 1, 2017, and November 30, 2019. Bleeding scores and blood samples were collected during a single study visit. Coagulation factor levels were measured centrally, and targeted exome analysis was performed on 156 genes involved in thrombosis and hemostasis. Pathogenicity was assigned according to the Association for Clinical Genetic Science guidelines. ResultsRare genetic variants specific to the diagnosed RBD were found in 132 of 156 patients (85%). Of the 214 rare genetic variants identified, 57% (n = 123) were clearly pathogenic, 19% (n = 40) were likely pathogenic, and 24% (n = 51) were variants of unknown significance. No explanatory genetic variants were found in patients with plasminogen activator inhibitor type 1 deficiency or hyperfibrinolysis. A correlation existed between factor activity levels and the presence of a genetic variant in the corresponding gene in patients with rare coagulation factor deficiencies and alpha-2-antiplasmin deficiency. Co-occurrence of multiple genetic variants was present in a quarter of patients, but effect on phenotype remains unclear. ConclusionTargeted exome analysis may offer advantages over single-gene analysis, emphasized by a number of combined deficiencies in this study. Further studies are required to determine the role of co-occurring hemostasis gene variants on the bleeding phenotype in RBDs.

Duration of Dual Antiplatelet Therapy (DAPT) After an Acute Coronary Syndrome by Bleeding and Ischaemic Risk Scores: An ANZACS-QI Study

Duration of Dual Antiplatelet Therapy (DAPT) After an Acute Coronary Syndrome by Bleeding and Ischaemic Risk Scores: An ANZACS-QI Study

Periodontal Disease in Patients with Ischemic Stroke - an Exploratory Study.

The aim of this study was to assess the periodontal disease parameters in patients with ischemic stroke. The study included 21 patients with ischemic brain stroke and a control group that was matched in number, age, and gender. All participants underwent a standard periodontal examination. The inclusion criterion of this study was the presence of at least 15 teeth. Periodontal epithelial surface area, periodontal inflamed surface area (PISA), and periodontal disease stage were determined. All participants were given a questionnaire to determine oral health-related quality of life (OHQL). Stroke risk factors were assessed. Stroke patients had a significantly higher OHQL score than the control group (20.81 vs. 12.57) and a full-mouth plaque score (FMPS, 27.57 vs. 16.83), while full-mouth bleeding score (FMBS) was significantly higher in the control group than in the hospital group (10.17 vs. 6.42). For PISA, statistically significant negative correlations were found for smoking, cholesterol levels, and LDL levels, while significant positive correlations were found for FMBS, clinical attachment level and probing depth. Although PISA does represent the amount of periodontal tissue that is inflamed, tooth loss due to advanced periodontal disease combined with oral hygiene limitations imposed by the hospital setting and the stroke recovery process remain the most significant obstacles for a more meaningful understanding of the data represented by specific clinical, laboratory and various demographic parameters that characterize the two diseases.

Comparative evaluation of the efficacy of Triphala mouthwash and Curcumin mouthwash in the treatment of gingivitis – A randomized controlled study

BackgroundNumerous studies on Triphala and Curcumin mouthwashes were analyzed individually and no study has compared the efficacy of Triphala mouthwash to Curcumin mouthwash in the management of gingivitis. Although various mouthwashes have shown reduction of plaque and gingivitis the search is still on for an ideal mouthwash with minimum side effects and better patient acceptance. ObjectivesTo access the efficacy of all the mouthwashes in the management of gingivitis. MethodsBy purposive sampling, 81 patients of both sexes with gingivitis were randomized by lottery method into 3 groups - A, B and C. Group A received scaling and Triphala mouthwash, Group B received scaling and Curcumin mouthwash and Group C underwent scaling and received Chlorhexidine mouthwash. Oral hygiene was assessed using Plaque, Gingival and Bleeding indices at baseline,7th day and 14th day. The inter-group comparisons were analysed using One-way analysis of variance (ANOVA) and multiple comparisons using Tukey's Honest significant difference test (α = 0.05) and the intra-group comparisons for the indices across various time periods within each group were analysed using Repeated-measures ANOVA and Bonferroni-adjusted pairwise comparisons post hoc test (α = 0.05). The statistical significance was set at p ≤ 0.05. ResultsThe study has shown that herbal mouthwashes are as effective as chlorhexidine in treating gingivitis although curcumin mouthwash showed a greater potential in reducing gingival inflammation. ConclusionBoth Triphala and Curcumin mouthwashes were proven to be equally effective in reducing plaque, gingival and bleeding scores, although curcumin was better in reducing gingival inflammation. Hence herbal mouthwashes such as Triphala and Curcumin with no side effects can be considered as an alternative mouthwash to chlorhexidine.

#430 Risk factors for major bleeding in patients with non-valvular atrial fibrillation and CKD G3-G5D on oral anticoagulants

Abstract Background and Aims We previously published a register-based cohort study comparing direct oral anticoagulants (DOAC) and warfarin in patients with atrial fibrillation (AF) and chronic kidney disease (CKD) GFR category 3-5 (G3-G5) including patients on dialysis (G5D) (1). This study showed that DOAC was associated with lower risk of major bleeding but similar risk of ischemic stroke compared to warfarin. Bleedings were however more common than strokes, especially in advanced CKD (G5-G5D) where the risk of major bleeding was up to 10 times higher than the risk of stroke. Subsequently, the stroke- and bleeding risk in patients with AF and advanced CKD must be carefully evaluated when deciding on whether to prescribe oral anticoagulants (OAC) or not. Available stroke- and bleeding scoring systems do not perform well in CKD (2, 3). This study aims to present risk factors associated with major bleeding in a Swedish cohort of OAC-treated patients with CKD G3-G5D. Method Data was collected from high quality Swedish healthcare registers including Swedish Renal Registry and Auricula, a register for atrial fibrillation and oral anticoagulants and the National Patient Register. Patients with eGFR<60 ml/min/1.73m2 and non-valvular atrial fibrillation and either DOAC (apixaban, rivaroxaban, edoxaban and dabigatran) or warfarin treatment between 2009-2018 where included. DOAC treatment periods were collected from the Swedish Prescribed Drug Register (PDR), starting from dispense date covering assumed standard pill use and an additional 30 days grace period. Warfarin treatment periods were collected directly from Auricula. An undefined treatment was a period of no OAC or a period of warfarin from PDR not matching a treatment period in Auricula. All periods of OAC treatment with either DOAC or warfarin were evaluated in a multivariate Cox regression model regarding the risk of major bleeding requiring inpatient care. Time-dependent covariates adjusted for in the model were age, sex, years from study start, GFR category, congestive heart failure, diabetes mellitus, hypertension, excessive alcohol use, liver disease, vascular disease, previous gastrointestinal bleeding, intracranial bleeding, other bleeding, ischemic stroke/ transient ischemic attack (TIA), myocardial infarction, PCI and exposures (DOAC, warfarin and periods of undefined treatment). Results Of 2453 included patients, 59% had warfarin (time in therapeutic range, TTR, 67%) and 41% DOAC at inclusion, predominantly apixaban (81% of DOAC users). The mean age was 77 years, 28.3% had G3, 45.4% G4, 9.1% G5 and 17.3% G5D (Table 1). Mean follow up was 2.2 years. During follow up 424 major bleedings occurred yielding 8.9 (95% confidence interval 8.1-9.8) bleedings per 100 patient-years. Table 2 shows effect estimates of each covariate on the outcome major bleeding. Covariates, besides warfarin, associated with increased risk of major bleeding were GFR category, G5/5D versus G3, hazard ratio 1.92 (95% CI 1.43-2.56), previous GI bleeding, 1.77 (1.39-2.25) and previous other bleeding 1.33 (1.09-1.62). Other factors associated with major bleeding were congestive heart failure 1.36 (1.11-1.68), male sex 1.28 (1.03-1.60) and vascular disease, 1.35 (1.01-1.79). Conclusion Patients with non-valvular atrial fibrillation and CKD G3-G5D on OAC are at high risk of major bleeding. Previous major bleeding and kidney failure are strongly associated with major bleeding, this reiterates the results of many previous studies. The present study also shows an association between OAC-associated major bleeding in CKD and male sex, congestive heart failure and vascular disease. Similar associations have been showed in non-CKD cohorts previously but is inadequately studied in CKD. Knowledge about risk factors for major bleeding on OAC in advanced CKD is essential when deciding on when to anticoagulate or not.

Reversal or Repletion Treatment Strategies and Outcomes of Patients With Major Bleeding Events Managed in the Emergency Department: Large Real-Life Investigation in the Northwestern Healthcare District of Tuscany.

To verify the incidence of bleeding events in patients on ongoing anticoagulant treatment in the real world and compare the results of different reversal or repletion strategies currently available for pharmacological treatment. Patients managed in the emergency department (ED) with major bleeding events, on ongoing anticoagulation were stratified according to bleeding site and reversal or repletion therapy with andexanet alfa (ADX), idarucizumab (IDA), prothrombin complex concentrate (PCC), and vitamin K (Vit-K). Death at 30 days was compared in the subgroups with cerebral hemorrhage (CH) and gastrointestinal (GI) bleeding. Of the 809,397 visits in the years 2022-2023 at 6 EDs in the northwestern health district of Tuscany, 5372 patients with bleeding events were considered; 3740 were excluded due to minor bleeding or propensity score matching. Of the remaining 1632 patients with major bleeding, 548 on ongoing anticoagulation were enrolled; 334 received reversal or repletion agents. Patients with CH (n = 176) and GI bleeding (n = 108) represented the primary analysis cohorts in the study's strategic treatment assessment. Overall, 30-day survival of patients on ongoing aFXa treatment receiving on-label ADX versus off-label PCC showed a relative increase of 71%, while 30-day survival of patients on ongoing aFII receiving on-label IDA versus off-label PCC showed a relative increase of 30%; no substantial difference was found when comparing on-label PCC combined with Vit-K versus off-label Vit-K alone. Indeed, patients undergoing on-label ADX or IDA showed a statistically significant difference over off-label PCC (ADX vs. PCC: n = 15, events = 4, mean ± SD 82.50 ± 18.9, vs. 49, 13, 98.82 ± 27, respectively; analysis of variance [ANOVA] variance 8627; P < 0.001; posthoc test diff 32, 95% confidence interval: 28-35; P < 001; IDA vs. PCC: 20, 5, 32.29 ± 15.0 vs. 2, 1, 28.00 ± 0.0, respectively; ANOVA 1484; P < 0.001; posthoc test -29, -29 -29, respectively; P = n.d.). On-label PCC combined with Vit-K showed overall a slight statistically significant difference versus off-label Vit-K alone (52, 16, 100.58 ± 22.6 vs. 53, 11, 154.62 ± 29.8, respectively; ANOVA 310; P < 0.02; posthoc test 4, 0.7-7.2, respectively; P < 0.02). Data were confirmed in the group of patients with CH (ADX vs. PCC: n = 13, events = 3, mean ± SD 91.55 ± 18.6 vs. 78, 21, 108.91 ± 20.9, respectively; ANOVA variance 10,091, F = 261; P < 0.001; posthoc difference test 36, 95% confidence interval: 30-41; P < 0.001; IDA vs. PCC: 10, 2, 4.50 ± 2.5 vs. 78, 21, 108.91 ± 20.9, respectively; ANOVA 16,876,303, respectively; P < 0.001; posthoc test 41, 34-47, respectively; P < 0.001). On-label PCC combined with Vit-K showed an overall slight statistically significant difference compared with off-label Vit-K alone (P < 0.01 and P < 0.001 in the subgroups of CH and GI bleeding). Patients undergoing specific reversal therapy with on-label ADX or IDA, when treated with aFXa or aFII anticoagulants, respectively, showed statistically elevated differences in 30-day death compared with off-label repletion therapy with PCC. Overall, 30-day survival of patients on ongoing aFXa or aFII receiving on-label reversal therapy with ADX or IDA compared with off-label PCC repletion agents showed an increase of 71% and 30%, respectively.

The Association between Salivary Metabolites and Gingival Bleeding Score in Healthy Subjects: A Pilot Study.

Periodontal diseases, including gingivitis and periodontitis, are among the most prevalent diseases in humans. Gingivitis is the mildest form of periodontal disease, characterized by inflammation of the gingiva caused by the accumulation of dental plaque. Salivary diagnostics are becoming increasingly popular due to the variation in saliva composition in response to pathological processes. We used a metabolomics approach to investigate whether a specific saliva metabolic composition could indicate preclinical stage of gingivitis. 1H-NMR spectroscopy was used to obtain the salivary metabolite profiles of 20 healthy subjects. Univariate/multivariate statistical analysis evaluated the whole saliva metabolite composition, and the Full-Mouth Bleeding Score (FMBS) was employed as a classification parameter. Identifying a signature of specific salivary metabolites could distinguish the subjects with high FMBS scores but still within the normal range. This set of metabolites may be due to the enzymatic activities of oral bacteria and be associated with the early stages of gingival inflammation. Although this analysis is to be considered exploratory, it seems feasible to establish an FMBS threshold that distinguishes between the absence and presence of early inflammatory alterations at the salivary level.

Healing of Periodontal Suprabony Defects following Treatment with Open Flap Debridement with or without Hyaluronic Acid (HA) Application.

Background and Objectives: This randomized, double-arm, multicentric clinical trial aims to compare the clinical outcomes following the treatment of suprabony periodontal defects using open flap debridement (OFD) with or without the application of hyaluronic acid (HA). Materials and Methods: Sixty systemically healthy patients with at least two teeth presenting suprabony periodontal defects were randomly assigned with a 1:1 allocation ratio using computer-generated tables into a test (OFD + HA) or control group (OFD). The main outcome variable was clinical attachment level (CAL). The secondary outcome variables were changes in mean probing pocket depth (PPD), gingival recession (GR), full-mouth plaque score (FMPS), and full-mouth bleeding score (FMBS). All clinical measurements were carried out at baseline and 12 months. Results: Sixty patients, thirty in each group, were available for statistical analysis. The mean CAL gain was statistically significantly different (p < 0.001) in the test group compared with the control group (3.06 ± 1.13 mm vs. 1.44 ± 1.07 mm). PPD reduction of test group measurements (3.28 ± 1.14 mm) versus the control group measurements (2.61 ± 1.22 mm) were statistically significant (p = 0.032). GR changes were statistically significant only in the test group 0.74 ± 1.03 mm (p < 0.001). FMBS and FMPS revealed a statistically significant improvement mostly in the test group. Conclusions: Suprabony periodontal defects could benefit from the additional application of HA in conjunction with OFD in terms of improvement of the clinical parameters compared with OFD alone.

ATRIAL FIBRILLATION IN A CIED POPULATION: RESULTS FROM A TELEMONITORING FOLLOW–UP

Abstract Background Telemedicine has emerged as a crucial tool in managing patients with Cardiac Implantable Electronic Devices (CIED), addressing the common challenge of the Atrial Fibrillation (AF) in cardiology. The incidence of AF in CIED recipients varies widely (30–70%), influenced by implant indication, device type, and population characteristics. This study aims to evaluate AF in an unselected, real–world CIED population, considering patients’ characteristics and the remote follow–up. Methods and Results 808 consecutive CIED recipients were evaluated between 2021 and 2023 in two Italian Division of Cardiology by collecting patients’ baseline characteristics and the scheduled remote follow–up data. Mean age was 75.6±12.6 years, 42% were females. 16.7% of the population was working actively and 73% of individuals were assisted by at least one caregiver, reflecting a diminished quality of life (EQ–5D score 8.9±4.3). Over a median follow–up of 20.6 months, 8.9% of patients died. 68.8% of the patients received a pacemaker, 19.3% an ICD and 11.9% a loop recorder. History of AF was present in 40.1% of the population, with a prevalence of permanent AF (46.6%). Ongoing anticoagulant therapy was documented in 303 patients (37.5%), 71% of whom were taking direct oral anticoagulants. Baseline CHA2DS2–VASC score was ≥3 in 79.7%, and the median HAS–BLED score was 1. During the observation period, scheduled remote transmissions revealed 719 AF episodes (15.7 episodes/patient/year), causing 21% of the overall remote alarms. Among patients without AF history, 69 (14.3%) experienced AF episodes (4.8 episodes/patient/year). Notably, 21.8% of the AF episodes lasted less than 10 minutes. Conclusions The wide spreading of heart rhythm monitoring technologies reveals the challenge of the subclinical AF in healthcare systems. This study, encompassing an unselected CIED population of elderly and frail patients with high AF prevalence, highlights AF as a primary cause of remote alerts and a substantial burden in telemonitoring controls. Telemedicine facilitated new AF diagnoses in 14.3% of individuals without a prior AF history and resulted a valuable tool considering the significant cardioembolic risk in these patients. However, the initiation of anticoagulation therapy remains debatable, especially for episodes of brief duration which in our experience exceeded 20% of the cases.

Comparative Study of Systemic vs. Local Antibiotics with Subgingival Instrumentation in Stage III-IV Periodontitis: A Retrospective Analysis.

To improve the clinical and microbiological outcomes of non-surgical mechanical periodontal therapy, the adjunctive use of antimicrobials has been utilized in treating moderate-to-severe periodontitis. In our study, the retrospective design included previously collected health-related patient data, obtained from the printed and digital charts of patients who received systemic or local antibiotic adjuncts to SI (subgingival instrumentation). A total of 34 patients (diagnosed with generalized Stage III/IV periodontitis) met the inclusion and exclusion criteria and were evaluated. The samples were tested for the following bacterial strains: Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Porphyromonas gingivalis (P. gingivalis), Prevotella intermedia (P. intermedia), Tanererella forsythia (T. forsythia), and Treponema denticola (T. denticola). The inter-group comparisons of the bacterial species did not show statistically significant differences between groups. The present study aimed to evaluate the clinical effects after SI and the adjunctive use of systemically administered (SA) AMX (amoxicillin) + MET (metronidazole) (administered for 7 days), with locally delivered (LDD) piperacillin + tazobactam in step 2 of periodontal therapy. Results: Overall, all parameters were improved in the groups, with a significant difference in inter-group comparison regarding the full-mouth bleeding score (FMBS) (p < 0.05) in favor of the SA group, and the p-value < 0.05 was considered to be statistically significant. Statistically significant PPD (probing pocket depth) reductions and CAL (clinical attachment level) gains were observed in both groups at the 3-month follow-up. In conclusion, within the limitations, the outcomes of this study suggest that SI, with adjunctive local or systemic antibiotic therapy, provided comparable clinical improvements. Systemic AMX + MET protocols were more efficacious with regard to the reduction in FMBS. Follow-up studies with larger patient numbers are needed to further investigate this effect.

Transanal eco-Doppler evaluation after hemorrhoidal artery embolization.

Hemorrhoidal artery embolization (Emborrhoid) is a novel method for the treatment of severe hemorrhoidal bleeding. Despite having a technical success rate of 93%-100%, the clinical success ranges between 63% and 94%, with a rebleeding rate of 13.6%. To evaluate the effectiveness of this procedure in reducing hemorrhoidal flow and hemorrhoidal bleeding. This prospective observational pilot study was conducted at Division of General Surgery 1 and Tertiary Referral Pelvic Floor Center, Treviso Regional Hospital, Italy. In a 2 months period (February-March 2022), consecutive patients with hemorrhoidal bleeding scores (HBSs) ≥ 4, Goligher scores of II or III, failure of non-operative management, and a candidate for Emborrhoid were included. Endoanal ultrasound with eco-Doppler was performed preoperatively and 1 month after the procedure. The primary endpoint was to quantify the changes in arterial hemorrhoidal flow after treatment. The secondary endpoint was to evaluate the correlation between the flow changes and the HBS. Eleven patients underwent Emborrhoid. The overall pretreatment mean systolic peak (MSP) was 14.66 cm/s. The highest MSP values were found in the anterior left lateral (17.82 cm/s at 1 o'clock and 15.88 cm/s at 3 o'clock) and in the posterior right lateral (14.62 cm/s at 7 o'clock and 16.71 cm/s at 9 o'clock) quadrants of the anal canal. After treatment, the overall MSP values were significantly reduced (P = 0.008) although the correlation between MSP and HBS changes was weak (P = 0.570). A statistical difference was found between distal embolization compared with proximal embolization (P = 0.047). However, the coil landing zone was not related to symptoms improvement (P = 1.000). A significant difference in MSP changes was also reported between patients with type 1 and type 2 superior rectal artery (SRA) anatomy (P = 0.040). No relationship between hemorrhoidal grades (P = 1.000), SRA anatomy (P = 1.000) and treatment outcomes was found. The preliminary findings of this pilot study confirm that Emborrhoid was effective in reducing the arterial hemorrhoidal flow in hemorrhoidal disease. However, the correlation between the post-operative MSP and HBS changes was weak. Hemorrhoidal grade, SRA anatomy and type of embolization were not related to treatment outcomes.

Differential efficacy of medical therapies for ulcerative colitis according to disease extent: patient-level analysis from multiple randomized controlled trials

Disease extent in Ulcerative Colitis (UC) has prognostic implications for disease course. It is unclear whether the efficacy of medical therapies for moderate to severely active UC vary according to disease extent at enrollment. We analyzed patient level data from 11 Phase 2 and 3 clinical trials of advanced therapies in patients with moderate-to-severe UC to assess modifications of advanced therapy effects by disease extent. Primary outcome was clinical response and secondary outcomes were clinical remission, endoscopic response/remission and endoscopic improvement, and Mayo clinic subscore for both induction and maintenance studies. Binary and continuous outcomes were analyzed using the modified Poisson regression model and the mixed-effects model, respectively, adjusting for age, sex, disease duration, concomitant steroid use and prior anti-TNF use. Effect modifications with binary outcomes were quantified by ratios of risk ratio for left-sided to that for extensive colitis while effect modifications with the Mayo subscores were quantified by differences of the differences between mean scores of the left-sided and extensive colitis. Results were presented with point estimates and 95% confidence intervals as well as p-values. Eleven clinical trials enrolling 5450 UC patients (infliximab=2, adalimumab=2, golimumab=2, vedolizumab=2, tofacitinib=3) were included. In induction trials, there was evidence to suggest effect modification by disease extent for clinical response with tofacitinib (the ratio of RRs 0.67, 95% CI [0.45, 0.99], p=0.049) and clinical remission with infliximab (ratio of RRs 0.33, 95% CI [0.13, 0.85], p=0.020) favoring patients with extensive colitis. There was no evidence to suggest effect modification for endoscopic improvement and clinical outcomes. There was evidence to suggest effect modification by disease extent for clinical remission with tofacitinib (ratio of RRs 0.44, 95% CI [0.22, 0.89], p=0.020) favoring patients with extensive colitis. For symptom subscores from the Mayo Clinic score, tofacitinib was associated with a greater reduction in both stool frequency (difference of differences 0.37, 95% CI [0.08, 0.65], p=0.012) and rectal bleeding scores (difference of differences 0.25, 95% CI [0.03, 0.47], p=0.026) in patients with extensive colitis compared to left sided. These findings underscore the possibility of differential efficacy of medical therapies according to disease distribution. These results warrant further exploration in forthcoming trials to better inform treatment strategies and consideration of disease distribution as a baseline stratification factor in clinical trials. This study did not receive any financial support.

Effects of minimally invasive non-surgical therapy on C-reactive protein, lipoprotein-associated phospholipase A2, and clinical outcomes in periodontitis patients: A 1-year randomized, controlled clinical trial.

Growing evidence suggests the type of periodontal treatment could differentially influence the reduction of key cardiovascular risk mediators in periodontitis patients. This randomized, controlled clinical trial compared the impact of minimally invasive non-surgical therapy (MINST) with quadrant-wise subgingival instrumentation (Q-SI) on C-reactive protein (CRP) together with lipoprotein-associated phospholipase A2 (Lp-PLA2) levels, and clinical periodontal outcomes in patients with periodontitis. Moreover, it was evaluated if baseline CRP levels impacted the efficacy of non-surgical periodontal therapy protocols. Forty-two periodontitis patients were enrolled and randomly treated by means of MINST (n=21) or Q-SI (n=21). The outcomes assessed were serum CRP and Lp-PLA2, and periodontal parameters (probing depth [PD], clinical attachment level [CAL], full-mouth bleeding score [FMBS]), at baseline and at follow-ups at 1, 3, and 6 months and at 1 year after treatment. At 1 year, MINST significantly reduced, among others, mean PD (p=0.007), mean CAL (p=0.007), the number of pockets>4mm (p=0.011) and ≥6mm (p=0.005), and FMBS (p=0.048) compared to Q-SI. Generalized multivariate analysis evidenced that high baseline CRP (p=0.039) and FMBS (p=0.046) levels, together with MINST treatment (p=0.007) were significant predictors of PD reduction at 1-year follow-up. Moreover, the Jonckheere-Terpstra test showed that patients with high baseline CRP levels gained more benefits from MINST treatment at 1-year follow-up than they did from Q-SI. Patients receiving MINST showed a greater reduction in CRP levels than patients with Q-SI after 1 year of follow-up. Moreover, patients with high baseline levels of CRP and Lp-PLA2 gained more benefits from the MINST approach at 1-year follow-up.

Clinical efficacy and safety evaluation of Dermatophagoides farinae drops in the treatment of allergic rhinitis with epistaxis.

Background. Epistaxis is frequently observed in allergic rhinitis (AR) patients. However, few studies focus on the outcome of epistaxis with treatment of AR patients. This study aimed to retrospectively analyze the efficacy and safety of AR patients with epistaxis treated with sublingual immunotherapy (SLIT). Methods. A total of 74 patients aged 4-60 years with house dust mite (HDM)-induced AR accompanied by epistaxis and who completed 1 year of SLIT treatment with standard Dermatophagoides farinae (D. farinae) drops were enrolled in this study. The symptom scores, total medication scores (TMS), combined symptom and medication score (CSMS), visual analog scales (VAS), and bleeding score (BS) were assessed, as well as the nasal endoscopic examinations were performed to observe nasal signs. Results. The levels of symptom scores, TMS, CSMS, VAS, and BS at 0.5 year and 1 year of SLIT treatment were significantly lower than those at the baseline (all p less than 0.01). Also, statistical differences were seen in CSMS (p less than 0.05) and VAS (p less than 0.01) between 0.5 year and 1 year. As expected, BS was positively correlated with CSMS (r = 0.617, 95% CI 0.517-0.699) and VAS (r = 0.777, 95% CI 0.719-0.822) at all three time points. Conclusions. SLIT with D. farinae drops was effective and safe for AR patients with epistaxis, resulting in improving the symptoms of rhinitis while relieving the symptoms of epistaxis.

Validation of the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) risk scores for venous thromboembolism and bleeding in an independent population

BackgroundMultiple guidelines recommend assessment of bleeding and venous thromboembolism (VTE) risk in adult medical inpatients to inform prevention strategies. There is no agreed-upon method for VTE and bleeding risk assessment. ObjectivesTo validate the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE and bleeding risk scores in an independent population. MethodsIn this retrospective study, we calculated the IMPROVE VTE and bleeding risk scores in medical inpatients admitted between 2010 and 2019 at the University of Vermont Medical Center (UVMMC). Patients were followed for in-hospital bleeding events while hospitalized and VTE events while hospitalized and for 3 months after discharge. We assessed calibration of the risk models by comparing the observed incidence of events in the UVMMC and IMPROVE populations across the published risk categories. We also assessed performance of the IMPROVE risk factors after refitting the models in the UVMMC population. Discrimination was assessed using the area under the receiver operating characteristic curve (AUC). ResultsVTE occurred in 270 (1.1%) of 23,873 admissions, with 92 (34%) occurring during admission, and bleeding occurred in 712 (4.7%) of 15,240 admissions. When the IMPROVE-VTE risk factors were refitted to the UVMMC data, the AUC was 0.64. When the IMPROVE bleeding risk factors were refitted to the UVMMC data, the AUC was 0.67. The IMPROVE-VTE score tended to overestimate risk at higher scores, and the IMPROVE bleeding score underestimated risk at lower scores and overestimated risk at higher scores. ConclusionWhile the refitted IMPROVE VTE and bleeding risk scores had reasonable model fit, the scores were poorly calibrated and did not reliably identify or differentiate patients at risk for VTE and bleeding. Different methods are needed for risk assessment of medical inpatients for VTE and bleeding risk.

First and second-generation endometrial ablation devices: A network meta-analysis

ObjectiveFirst-generation and second-generation endometrial ablation (EA) techniques, along with medical treatment and invasive surgery, are considered successful lines of management for abnormal uterine bleeding (AUB). We set out to determine...

Efficacy and safety of intravenous tranexamic acid in microscopic modified radical mastoidectomy: a study protocol for a prospective, randomised, double-blind controlled trial

IntroductionRadical mastoidectomy is a common procedure for chronic suppurative otitis media, typically performed under a microscope. The smooth operation is closely related to the clarity of the operative field. Our...

Gynecological bleeding in women with congenital bleeding disorders: A comprehensive cohort from Iran

BackgroundGynecological bleeding including menorrhagia and postpartum hemorrhage (PPH) face women's quality of life constantly with difficulties, especially those suffering from inherited bleeding disorders. In this study, we aim to evaluate gynecological bleeding particularly menorrhagia among Iranian women patients with inherited bleeding disorders admitted to the Iranian Comprehensive Hemophilia Care Center (ICHCC). MethodsThis study was conducted on 156 females aged ≥ 12 diagnosed with an inherited bleeding disorder in ICHCC. Demographic and laboratory data were documented for all patients. Bleeding questionnaires (the International Society on Thrombosis and Hemostasis bleeding assessment tool (ISTH-BAT), Molecular and Clinical Markers for the Diagnosis and Management of Type 1 von Willebrand disease (MCMDM-1), and Pictorial blood loss assessment chart (PBAC)) were filled out for all patients. For comparing metric and categorical parameters, Mann-Whitney was performed. Spearman's rho test was used for analyzing correlation. ResultsThe mean age of patients was 33. Von Willebrand disease (VWD), Factor (F) VII deficiency and combined factor deficiency were the most diagnosed disorders. The median of ISTH-BAT, MCMDM-1, and PBAC was 7,7, and 517, respectively. Menorrhagia was the most common reason for diagnosis. Menorrhagia and PPH domain scores ≥ 2 were recorded in 82 and 34 patients, respectively, and PBAC scores > 100 were seen in 118 patients. Significant positive correlations were observed between bleeding scores and menorrhagia and PPH scores. No significant correlations were recorded for VWF: Ag and VWF: RCo with menorrhagia and PPH scores; however, significant correlations were seen for VWF: Ag and VWF: RCo with bleeding score questionnaires. ConclusionMenorrhagia is the most common problem in females affected by different types of inherited bleeding disorders, particularly VWD. Increased awareness among gynecologists and hematologists about bleeding disorders in cases with unexplained menorrhagia is an essential step for optimal management.